System with a pluggable data transfer module which transfers data from an analytical system to a data processing unit

ABSTRACT

The invention concerns a pluggable data transfer module and a method that can be used to transfer data from an analytical system to a data processing unit in a galvanically decoupled manner. This invention is particularly suitable for medical fields of application in which recently it has become more and more desirable to process analytical data of a patient.

[0001] The invention concerns a system with a pluggable data transfermodule which converts electrical data from an analytical system andtransfers these converted data in a galvanically decoupled form to adata processing unit. Hence the present invention relates to the fieldof data transfer.

[0002] Recently such data transfer between an analytical system and adata processing unit has proven to be increasingly useful since it isoften desirable to process analytical data which for example simplifiesa continuous monitoring of analytical data. A continuous monitoring ofanalytical data or for example a statistical evaluation of these dataare only a few possibilities for optimizing an analytical process or itsapplication.

[0003] Although data processing offers various advantages, it oftenproves to be too voluminous to be performed by conventional analyticalinstruments alone. Consequently additional constructional measures wouldbe required to implement data processing by means of an analyticalsystem which would increase the manufacturing costs. Hence a dataprocessing unit is often not integrated into the analytical system forcost reasons and separate data processing units such as a PC are usedinstead. One of the advantages of this is that a data processing unitdoes not need to be integrated as a standard feature and thus themanufacturing costs of analytical instruments for fields of applicationin which data processing is not required are not unnecessarilyincreased. One field of application in which a reduction ofmanufacturing costs is important is for example the medical field. Thisapplies in particular to the medical field of application in which theanalytical instruments are intended for personal use. The reason forthis is that the selling price is an important buying criterion foranalytical systems that are sold to private individuals.

[0004] Despite the problems of cost effective instrument manufacture,the ability to process data will become more and more indispensable inthe future since processing and evaluation of analytical data oftenproves to be useful particularly in the medical field.

[0005] This should simplify and improve monitoring of the state ofhealth and optimization of treatments for private individuals.

[0006] In practice it turns out that, one the one hand, especiallymodern patients desire an autonomous management of their analytical datafor an independent and optimized handling of their disease but, on theother hand, data processing is often unused since the operators ofanalytical instruments are often elderly persons who are not familiarwith the modern methods of data processing.

[0007] Hence it is desirable to firstly only offer customers thepossibility of data processing without incurring additional costs. Withrespect to further cost reduction the data processing should not only becarried out externally but instrument components for data processingthat are already present integrated into the analytical instrumentshould be excluded from the analytical instrument. Such an instrumentcomponent is for example used to transfer data from the analyticalinstrument to an external data processing unit. Such a data transfermodule is offered separately to the customer as an additional componentand can be connected to the analytical instrument when required. Thisenables the operator to decide for himself whether to incur additionalcosts for his own data processing.

[0008] However, the provision of a separate data processing unit as anadditional component of an analytical instrument requires that theconnection of the data processing unit to the analytical instrument issimple to handle. Furthermore such a connection of a data transfermodule should be inexpensive and not require complicated constructionalmeasures, e.g. on the analytical instrument, so that the offer of anadditional data processing remains attractive. An inexpensive connectionof a data transfer module is disclosed in the prior art which utilizes acalibration module interface, which is usually already present as aninterface, for a data transfer module.

[0009] A calibration module interface on an analytical system is used toconnect a so-called calibration module. The calibration module containscoding which is stored on a chip and whose data are used to calibratemeasuring data of an analytical instrument. Such a calibration is forexample used to compensate for lot variations in the reagent system.

[0010] Examples of such systems are known from Roche Diagnostics GmbHwhich are used to measure blood sugar (AccuChek Advantage Family®). Withsuch a glucose measuring instrument glucose is determined by means oftest strips on which a sample is applied. The sample reacts with areagent system of the test strip in such a manner that the glucosecontent of the sample can be quantified by the analytical instrument.The aforementioned calibration module which is often referred to as acodekey is for example enclosed in a pack of test strips in order toallow for lot-to-lot variations which occur in the manufacture of thetest strips. For this purpose the calibration module is connected to theinterface that is provided and the coding stored on a chip can be readout. The measured data are corrected in the analytical instrument bymeans of the coding.

[0011] In order to transfer data between the analytical instrument and adata processing unit the calibration module is removed in the prior artfrom the interface such that the interface can be used for datatransfer. For this purpose a data transfer cable is used in theinterface. The previously measured and stored data are transferred tothe data processing unit by means of the data transfer cable by forexample connecting the data transfer cable to a PC. The data can thenfor example be transferred by means of the PC software CAMIT® from RocheDiagnostics GmbH.

[0012] Suitable cables which can communicate with a calibration moduleinterface are for example provided by Roche Diagnostics GmbH under thename “AccuChek Interface Cable®” or “Professional Cable®”.

[0013] However, a disadvantage of the prior art is that an electricalcontact has to be made between the analytical instrument and the mainsvoltage of the data transfer unit for the data transfer. There is apotential risk to the customer that he may come into contact with themains voltage via the contact chain: mains voltage-PC-analyticalinstrument-test strips-blood drop-user.

[0014] Hence when using such analytical instruments it is often noted inthe manual that there is a risk to the user of electrification by thedata transfer cable which is connected to the data processing unit whichrequires special precautionary measures in its operation.

[0015] The object of the invention is to design an analytical systemwith a pluggable data transfer module which allows a convenient,economical and reliable evaluation of analytical data. In particularelectrical contact with the data processing unit should be avoidedduring the transfer of data.

[0016] The invention concerns a pluggable data transfer module whichcontains an interface which is compatible with a calibration moduleinterface of an analytical instrument and allows data transfer ofelectrical signals between the data transfer module and the analyticalinstrument. The data transfer module additionally contains a convertingunit which converts the electrical signals into electromagnetic oracoustic signals or converts electromagnetic or acoustic signals intoelectrical signals, and a communication unit which allows the datatransfer of electromagnetic or acoustic signals between the datatransfer module and a data processing unit.

[0017] Electromagnetic signals in the sense of the invention are forexample optical signals.

[0018] Another aspect of the invention is an analytical system with apluggable data transfer module which transfers data from an analyticalinstrument to a data processing unit comprising an analytical instrumenthaving an interface to which a calibration module or, alternatively apluggable data transfer module can be attached, and a pluggable datatransfer module. The data transfer module has an interface which allowsdata transfer of electrical signals between the data transfer module andthe interface of the analytical instrument. The electrical signals areconverted into electromagnetic or acoustic signals, or electromagneticor acoustic signals are converted into electrical signals with the aidof a converting unit.

[0019] Consequently a converting unit in the sense of the invention canconvert electrical signals into acoustic signals as well as intoelectromagnetic signals as required. However, it is also conceivablethat a conversion of electrical signals into exclusively acoustic orelectromagnetic signals is sufficient and hence the module is onlysuitable for one type of signal conversion. Irrespective of the type ofsignal conversion, a signal conversion usually comprises the ability toconvert electrical signals into non-electrical signals and thecomplementary path of transforming non-electrical signals intoelectrical signals. A simplified embodiment which only allows onedirection of signal conversion and does not allow the complementarydirection is of course conceivable independent of the respective fieldof application.

[0020] A communication unit enables data transfer of the electromagneticor acoustic data between the data transfer module and a data processingunit.

[0021] Hence the invention simplifies the handling for the user by meansof a pluggable contact which ensures a rapid connection of the datatransfer module to an analytical instrument. In this manner data fromthe analytical instrument can be exchanged with the data transfer modulevia the interface. The data transfer module converts the signals. Thisenables data to be exchanged between the data transfer module and dataprocessing unit which ensures galvanically decoupled data transfer.There is no risk to the user that he may for example come into contactwith the mains voltage of a PC. Other handling advantages are due to thefact that data transfer occurs through space and no connection isnecessary, for example by a cable, between the data transfer module andthe data processing unit.

[0022] An infrared module may for example be integrated into the datatransfer module which is suitable for transmitting and receiving IRradiation such that data can be transferred by means of an IRtransmitter to the data processing unit. The data transfer module isthen able to convert electrical signals into IR signals or to convert IRsignals into electrical signals. The data processing unit detects thesignals for example by means of an IR receiver. The IR module can beadvantageously be constructed such that the signals can be detected bycommercial IR receiver/transmitting units such as those that are forexample used on PCs. Hence data can be transferred over a spatialdistance of ca. 1 m with commercial transmitter/receiver power.

[0023] The use of a microcontroller has proven to be particularlysuitable under the said conditions and offers space, cost and functionaladvantages for the data transfer module such that for example therequired circuits, impulse modulation and automatic voltage cut-out areintegrated in one component. This for example ensures that data transferdoes not occur until the analytical instrument is ready to operate inorder to prevent erroneous data transfer.

[0024] However, it is also possible to use a radio module which issuitable for transmitting and receiving RF signals. In this caseelectrical signals are converted into RF signals or RF signals areconverted into electrical signals.

[0025] However, if one does not wish to be limited to one particularsignal conversion in order to achieve a more diverse compatibility withdata processing units, it is of course also possible to utilize anydesired combination of signal-specific modules and signal converters. Inthis case a data transfer module would for example have an IR and an RFmodule.

[0026] In a preferred embodiment the analytical instrument is used, asalready described as an example, to measure glucose concentrations thatare determined using test elements. Since especially in the case ofdiabetes, glucose measurements are carried out several times per day,special analytical instruments for glucose measurement are manufacturedfor personal use. Diabetes is one of the main diseases where a goodmonitoring of the state of the disease is helpful to prevent damage suchas loss of sight. Hence in this case there is a great demand for diseasemonitoring with the aid of a suitable data management which can becarried out by the patient as required.

[0027] Of course any type of analytical instrument is conceivable withinthe scope of the invention such as for example instruments for measuringcoagulation.

[0028] In another preferred embodiment the analytical system contains acalibration module which is plugged into the interface of the analyticalinstrument. Such a calibration module (codekey) is usually included inthe pack when for example buying test elements. The customer is theninstructed to connect the calibration module with the analyticalinstrument via the interface so that the measured data can for examplebe corrected. The fact that the same interface of the analyticalinstrument is also suitable for connecting the instrument with the datatransfer module avoids additional measures when constructing ananalytical instrument. Hence the customer can decide on data processingat any time even if he did not take this into account when buying theanalytical instrument since it is only necessary to subsequentlypurchase a data transfer module according to the invention.

[0029] The data transfer module preferably obtains its energy from theanalytical system; but an energy supply unit may also be integrated intothe data transfer module.

[0030] If radio technology is integrated in the data transfer module, itis also possible, in addition to the said energy supplies, to obtainenergy from the instrument surroundings in the form of an energizingoscillation such that the data transfer module is a component of atransponder system. Transponder technology enables the module to obtainits energy passively from the instrument surroundings by means of thetransmitter antennae of the reading system which continuously suppliesenergy to the transponder via an alternating magnetic field.Transponders are completely maintenance-free and have a long life span.It is preferable to use the low frequency range (124 kHz or 62 kHz) sothat the data transfer module is not subject to any special safetyrequirements.

[0031] Another advantage of using a transponder is that data can bewritten on a microchip and hence this enables a reversible storage ofdata. Advantages of data storage are elucidated in more detail in thefollowing.

[0032] As already described there are in general several ways for a datatransfer module to be supplied with energy. Since the aforementionedanalytical instruments in the medical field are often battery-operatedinstruments it is desirable to have a low energy consumption. This canfor example be assisted by the data transfer module being used for asshort a period as possible. In a preferred embodiment the data transfermodule can be activated by contact with the instrument interface or by astart impulse of the data processing unit or of the analytical system.In a preferred embodiment the data transfer module is deactivated aftera defined period without data transfer. This ensures that the datatransfer module does not unnecessarily consume energy.

[0033] The transfer data can be processed with the aid of the dataprocessing unit.

[0034] In another preferred embodiment the data transfer module containsa storage device which, as described above, can be realized in the formof a transponder system enabling for example stored data to betransferred from the analytical system to the data processing unit evenwithout contact of the data transfer module. The data transfer modulepreferably automatically stores the transferred data which cansubsequently be removed from the analytical instrument. The datatransfer module is easy to transport due to its small size. Hence theuser is able to read out the stored data at a selected site withouthaving to also carry the analytical instrument. This is particularlysuitable for users who are not familiar with modern methods of datatransfer but who desire a monitoring of their data. Consequently thepreferred embodiment of the invention enables an easy-to-handle dataprocessing by persons who are not themselves able to process the dataand who can thus commission someone else to carry out the dataprocessing who is usually their attending physician. Hence the user doesnot have to deal with the steps of data processing which would otherwisebe necessary such as transfer of the data by internet or storing thedata on a storage medium etc.

[0035] Another aspect of the invention is a method for transferring databetween an analytical system and a data processing unit.

[0036] The method comprises plugging a pluggable calibration module intoan interface of the analytical system and unplugging it from theinterface after transferring the calibration module data to theanalytical system as well as plugging a pluggable data transfer moduleinto the interface of the analytical system and transferring electricalsignals of the analytical system to the data transfer module. Conversionof the electrical signals of the analytical system into electromagneticor acoustic signals by means of the data transfer module and transfer ofthe converted data to a data processing unit.

[0037] In a preferred embodiment of the method a data transfer module oran analytical system as described above is used.

[0038] A preferred embodiment of the data transfer module is suitablefor a method as described above and a preferred analytical systemcontains a data transfer module as described above.

[0039] Some examples are elucidated in more detail on the basis of thefollowing figures.

[0040]FIG. 1: analytical instrument for measuring glucoseconcentration—front and rear view.

[0041]FIG. 2: analytical instrument with a codekey

[0042]FIG. 3: analytical system comprising an analytical instrument anddata transfer module

[0043]FIG. 4: data transfer between the analytical system and dataprocessing unit

[0044]FIG. 1 shows a front view (1) of a glucose measuring instrumentwhich has an operating keyboard (2) and a slot for a test strip (3).After sample application a test strip is inserted into the slot (3) inorder to measure the glucose value in the analytical instrument. Theresult of the measurement is displayed to the user by means of thedisplay (4). The analytical instrument has another slot (6) on the rearside (5) to insert a calibration module. This calibration module isusually referred to as a codekey. Such a codekey is usually enclosed ina pack of test strips in order that the test strip chemistry can betaken into account when determining the concentration of glucose. Thiscodekey contains a coding which allows the measured values to becorrected when calculating the concentration and takes intoconsideration lot-specific variations of the test strips. The instrumentreads out the stored code and takes it into consideration in order todisplay a corrected measurement result on the screen. According to theinvention the slot (6) can also be used to connect the analyticalinstrument with a data transfer module. After removing the codekey fromthe interface, the data transfer module can be plugged into the freeinterface.

[0045]FIG. 2 shows an example of an analytical instrument (40) having acodekey (20) that is contacted with the analytical instrument as isalready known in the prior art.

[0046] The codekey has a plastic housing (22), a front view (21) ofwhich is also shown in FIG. 2. The plastic housing is designed to becompatible with the slot (6) of the analytical instrument. The data ofthe codekey are stored on the chip (23) and can be read out by theanalytical system after contacting the codekey.

[0047]FIG. 3 is a detailed illustration of the slot (6) and also showsan example of an infrared data transfer module (32) which contains aninfrared transmitter/receiver (33). After insertion of the data transfermodule (32), the analytical module is in contact with the data transfermodule via the contacts (31). The contact of the data transfer modulewith the analytical instrument automatically activates the data transfermodule after a defined time period. Electronic signals of previouslystored data on the analytical instrument are transferred via theinterface (31) to the data transfer module. The infrared transfer moduleis now able to convert the electrical signals into infrared signals.

[0048] The data transfer between the analytical instrument and dataprocessing unit is illustrated in FIG. 4. As soon as the infrared datatransfer module (32) has been inserted in the measuring instrument (40),the instrument is ready to receive and transmit data. Signals can noweither be transferred from the PC (43) to the analytical instrument (40)or vice versa. If data are transferred from the PC (43) to theanalytical instrument (40), a suitable software is firstly accessed onthe PC (43). The PC (43) transmits light impulses in the IR range viaits infrared module (44). The data transfer module (32) receives thetransmitted light impulses by means of an infrared receiver (33) andconverts these into electrical impulses. In this process a light impulseis for example assigned the numerical value 0 and the absence of a lightimpulse is assigned the numerical value 1. The data are placed on theinternal serial bus of the instrument. The data can be used for furtherprocessing by the analytical instrument. Hence it is for examplepossible to provide data processing not only by means of a PC. Also thedata obtained from the data processing can for example be used tocalibrate new measurement data in the analytical system.

[0049] Hence an analytical system having a data transfer moduleaccording to the invention can be used in many different ways to managemeasurement data which allows an optimization of for example theanalytical or treatment methods. The data transfer module which iseconomical and simple to use facilitates processing of the measurementdata for the user.

1. Pluggable data transfer module (32) comprising an interface which iscompatible with a calibration module interface of an analyticalinstrument (40) and enables data transfer of electrical signals betweenthe data transfer module (32) and the analytical instrument (40) and aconversion unit which converts electrical signals into electromagneticor acoustic signals or converts electromagnetic or acoustic signals intoelectrical signals and a communication unit (33) which enables datatransfer of electromagnetic or acoustic signals between the datatransfer module (32) and a data processing unit (43).
 2. Pluggable datatransfer module as claimed in claim 1 in which an infrared module isintegrated into the data transfer module.
 3. Pluggable data transfermodule as claimed in claim 1 in which a radio module is integrated intothe data transfer module.
 4. Pluggable data transfer module as claimedin claim 1 in which an energy supply unit is integrated.
 5. Pluggabledata transfer module as claimed in claim 1 in which the data transfermodule contains a storage device.
 6. Pluggable data transfer module asclaimed in claim 2, in which the data transfer module contains amicrocontroller.
 7. Analytical system having a pluggable data transfermodule (32) which enables data transfer between an analytical instrument(40) and a data processing unit (43) comprising an analytical instrument(40) with an interface to which a calibration module (20) oralternatively a pluggable data transfer module (32) can be attached) apluggable data transfer module (32) containing an interface whichenables data transfer of electrical signals between the data transfermodule (32) and the interface of the analytical instrument (40) and alsocontaining a conversion unit which converts electrical signals intoelectromagnetic or acoustic signals or converts electromagnetic oracoustic signals into electrical signals and also containing acommunication unit (33) which enables data transfer of electromagneticor acoustic signals between the data transfer module (32) and a dataprocessing unit (43).
 8. Analytical system as claimed in claim 7 inwhich the analytical instrument has an evaluation unit for test elementsand is preferably an instrument for measuring glucose concentrations. 9.Analytical system as claimed in claim 7 which contains a calibrationmodule which is plugged into the interface of the analytical instrument.10. Analytical system as claimed in claim 7 in which the data transfermodule obtains its energy from the analytical system.
 11. Analyticalsystem as claimed in claim 7 in which the data transfer module containsa radio module and is a component of a transponder system.
 12. Methodfor transferring data between an analytical system and a data processingunit (43) comprising plugging a pluggable calibration module (20) intoan interface of the analytical system (40) and unplugging it from theinterface after data has been transferred from the calibration module(20) to the analytical system (40), plugging a pluggable data transfermodule (32) into the interface of the analytical system (40) andtransferring electrical signals from the analytical system (40) to thedata transfer module (32), converting the electrical signals of theanalytical system (40) into electromagnetic or acoustic signals by meansof the data transfer module (32), transferring the converted data to adata processing unit (43).
 13. Method as claimed in claim 12 in whichthe data transfer module is activated by contact with the instrumentinterface.
 14. Method as claimed in claim 12 in which the data transfermodule is activated by a start impulse from the data transfer module orthe analytical system.
 15. Method as claimed in claim 12 in which thedata transfer module is deactivated after a defined time period in whichno data transfer has occurred.
 16. Method as claimed in claim 12 inwhich electrical signals are converted into IR signals or IR signals areconverted into electrical signals in the data transfer module. 17.Method as claimed in claim 12 in which electrical signals are convertedinto RF signals or RF signals are converted into electrical signals inthe data transfer module.
 18. Method as claimed in claim 12 in which thedata transfer module stores data and the stored data can be transferredto the data processing unit even if the data transfer module is not incontact with the analytical system.
 19. Analytical system as claimed inclaim 7 in which a pluggable data transfer module as claimed in one ofthe claims 16 is used.
 20. Method as claimed in claim 11 in which ananalytical system as claimed in one of the claims 7-11 is used. 21.Pluggable data transfer module as claimed in claim 1 which is used tocarry out a method as claimed in one of the claims 12-18.